FDA approves Roche’s new melanoma treatment
SILVER SPRING, Md. — The Food and Drug Administration on Wednesday announced that it had approved Roche’s Cotellic (cobimetinib), a treatment for patients with advanced metastatic melanoma that can’t be removed through surgery with a certain gene mutation (BRAF V600E or V600K). The drug is meant to be used in conjunction with vemurafenib.
“As we continue to advance our knowledge of tumor biology, we have learned that cancer cells have a remarkable ability to adapt and become resistant to targeted therapies. Combining two or more treatments addressing different cancer-causing targets may help to address this challenge,” said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval provides a new targeted treatment that, when added to vemurafenib, demonstrates greater benefit than vemurafenib alone in patients with BRAF mutation-positive melanoma.”
Perrigo gets FDA approval for generic KlorCon
DUBLIN — Perrigo on Wednesday announced that the Food and Drug Administration had approved the company’s generic KlorCon (potassium chloride) extended-release tablets.
The drug, which is indicated to treat and prevent hypokalemia, or low potassium levels, will be available in 600- and 750-mg dosage strengths. Sales of the drug for the 12 months ending Sept. 15 were $81 million.
Diplomat to dispense cancer treatment Cotellic in combination with Zelboraf
FLINT, Mich. – Diplomat Pharmacy announced Wednesday that it will dispense Cotellic (cobimetinib) in combination with the BRAF inhibitor Zelboraf (vemurafenib) to treat patients with advanced melanoma that is unresectable (cannot be removed by surgery) or metastatic (cancer that has spread from the primary site).
"We are excited to dispense this combination treatment for patients suffering from advanced melanoma," said Gary Kadlec, president of Diplomat. "Patients in search of a new treatment option have an opportunity to explore one, with a therapy that combines the advantages of these two medications for a lasting impact."
The combination of Cotellic with Zelboraf helps patients with previously untreated BRAF V600 mutation-positive advanced melanoma live a median of one year (12.3 months) without their disease worsening, compared to 7.2 months with Zelboraf alone.
Cotellic is designed to selectively block the activity of MEK, one of a series of enzymes that make up a signaling pathway that helps regulate cell division and survival. Zelboraf binds to and inhibits mutant forms of BRAF, another enzyme in the pathway, to interrupt abnormal signaling that can cause tumor growth.
Melanoma is less common, but more aggressive and deadlier than other forms of skin cancer. The BRAF gene is mutated in approximately half of all melanomas. According to the National Cancer Institute, an estimated 73,870 Americans will be diagnosed with melanoma this year and 9,940 will die from the disease.
Zelboraf was the first prescription treatment for patients with unresectable or metastatic melanoma with BRAF V600 mutation as detected by a validated test. Zelboraf is not indicated for use in patients with wild-type BRAF melanoma.
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